Neurostimulation device with recording patch

ABSTRACT

The present disclosure describes systems and methods for recording electrical activity, such as local field potentials. The system can include a recording patch that is placed inline between an implanted neurological lead and an implantable pulse stimulator. The recording patch can include recording and amplification circuitry that detects, records, and amplifies electrical activity (also referred to as signals) from a target site. The system can be used to select over which of the lead&#39;s electrodes therapeutic stimulations are delivered.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims benefit of priority under 35 U.S.C. § 120as a continuation of U.S. patent application Ser. No. 16/424,044, titled“NEUROSTIMULATION DEVICE WITH RECORDING PATCH,” filed May 28, 2019,which is incorporated herein by reference in its entirety.

BACKGROUND OF THE DISCLOSURE

Deep brain stimulation (DBS) is a neurostimulation therapy that caninvolve electrical stimulation systems that stimulate the human brainand body. DBS can be used to treat a number of neurological disorders.Typically, DBS involves electrically stimulating a target area of thebrain.

SUMMARY OF THE DISCLOSURE

The present disclosure describes systems and methods for recordingelectrical activity, such as local field potentials. The system caninclude a recording patch that is placed inline between an implantedneurological lead and an implantable pulse stimulator. The recordingpatch can include recording and amplification circuitry that detects,records, and amplifies electrical activity (also referred to as signals)from a target site. The system can be used to select over which of thelead's electrodes to deliver therapeutic stimulations. The system canselect the electrodes based on the amount of power within the beta bandof the signal or other characteristics of the signal.

According to at least one aspect of the disclosure, an implantabledevice can include a first port. The first port can be configured toreceive a connection from an implantable pulse stimulator. The firstport can include a first plurality of connections. The device caninclude a second port. The second port can be configured to receive aconnection from an implantable lead. The second port can include asecond plurality of connections. The device can include a plurality ofswitches. The switches can be configured to selectively interconnect, ata first time point, the first plurality of connections with the secondplurality of connections to pass a stimulation signal from theimplantable pulse stimulator to the implantable lead. The switches canselectively interconnect, at a second time point, the second pluralityof connections with a recording module. The recording module cangenerate an amplified biological signal based on a biological signalreceived from the second plurality of connections. The recording modulecan transmit the amplified biological signal to a receiver.

According to at least one aspect of the disclosure, a method can includeimplanting a recording patch into a subject. The recording patch caninclude a first port that can be configured to receive a connection froman implantable pulse stimulator. The first port can include a firstplurality of connections. The recording patch can include a second portthat can be configured to receive a connection from an implantable leadthat can include a plurality of electrodes. The second port can includea second plurality of connections. The recording patch can include aplurality of switches in electrical communication with the firstplurality of connections and the second plurality of connections. Therecording patch can include a recording module. The method can includecoupling, with the plurality of switches, the second plurality ofconnections with the recording module. The method can include receiving,at the second plurality of connections, biological signals from theimplantable lead. The method can include generating, by the recordingmodule, amplified biological signals based on the biological signals.The method can include determining at least one signal characteristic ofthe biological signals. The method can include selecting an electrode ofthe plurality of electrodes based on the at least one signalcharacteristic of the biological signal.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are not intended to be drawn to scale. Likereference numbers and designations in the various drawings indicate likeelements. For purposes of clarity, not every component may be labelledin every drawing. In the drawings:

FIG. 1 illustrates a front view of a subject implanted with an examplesystem for performing neurostimulation.

FIG. 2 illustrates a perspective view of the subject implanted with theexample system for performing neurostimulation.

FIG. 3 illustrates an enlarged view of the recording patch implantedbelow the subject's scalp.

FIGS. 4-6 illustrate enlarged views of the recording patch illustratedin FIGS. 1-3.

FIGS. 7A and 7B illustrate an example recording patch.

FIG. 8 illustrates a block diagram of an example schematic of the systemillustrated in FIGS. 1-3.

FIGS. 9A and 9B illustrate block diagrams example methods to recordbiological signals with the system described herein.

FIGS. 10-13 illustrate plots of the power spectral densities of signalsrecorded with the systems described herein.

FIG. 14 illustrates an example heat map of the amount of beta activityrecorded at each of the electrodes of the lead during a plurality ofactivities.

DETAILED DESCRIPTION

The various concepts introduced above and discussed in greater detailbelow may be implemented in any of numerous ways, as the describedconcepts are not limited to any particular manner of implementation.Examples of specific implementations and applications are providedprimarily for illustrative purposes.

The present disclosure describes a technical solution for performingneural recordings and stimulations. The system can include a recordingpatch that can be coupled inline between an implanted pulse stimulatorand a lead implanted into, for example, a subject's brain. The recordingpatch can receive biological signals from the subject's brain and canamplify the biological signals. The biological signals can be anyelectrophysiological signal generated by the patient, such as localfield potentials, single units, neural ensembles, or other electricalsignals generated by patient's brain or body. The recording patchtransmit the amplified signals to an external device. The externaldevice can also provide wireless power to the recording patch. Thesignals collected by the recording patch can be used to guide thesubject's therapy. For example, the recording patch or external deviceassociated with the recording patch can select stimulation electrodesbased on power distributions within specific frequency bands of theamplified signals. When not in use, the recording patch can be placedinto a pass-through mode that enables the stimulation signals from thepulse stimulator to pass substantially unchanged through the recordingpatch to the lead.

FIG. 1 illustrates a front view of a subject implanted with an examplesystem 50 for performing neurostimulation. FIG. 2 illustrates aperspective view of the subject implanted with the example system 50 forperforming neurostimulation. FIG. 3 illustrates an enlarged view of therecording patch 100 implanted below the subject's scalp 300.

The system 50 includes a recording patch 100 implanted below thesubject's scalp. The recording patch 100 is coupled with an implantablepulse stimulator 102, which is implanted into the subject 104. Therecording patch 100 is also coupled with an implantable lead 106. Animplantable lead 106 can be implanted into each hemisphere of thesubject's brain (or other location within the subject). The recordingpatch 100 can be coupled with the pulse generator 102 and the leads 106via cables 108.

The system 50 can include one or more recording patches 100. Therecording patches 100 are described further in relation to FIGS. 3-9,among others. The recording patch 100 can improve (or provide) therecording capabilities for the implantable pulse stimulator 102. Thepulse stimulator 102 can be a stimulation only device (e.g., the pulsestimulator 102 may not include recording capabilities) and the recordingpatch 100 can perform electrical recordings that are used to monitor thesubject's response to electrical stimulations and coordinate thesubject's therapy.

The recording patch 100 can be placed inline between the implantablepulse stimulator 102 and the leads 106. The implantable pulse stimulator102 can be configured to deliver electrical stimulation to the subjectvia the leads 106.

The recording patch 100 can amplify electrical signals (e.g., biologicalsignals) detected by the electrodes of the leads 106. The recordingpatch 100 can amplify the signals and transmit the amplified signalsexternally from the subject to, for example, an external programmer,which can also be referred to as a receiver. The recording patch 100 cancalculate or determine one or more characteristics of the signals andtransmit the characteristics of the signal externally from the subject.In some cases, the recording patch 100 can transmit the amplifiedsignals to an external programmer that can calculate the signalcharacteristics. The signal characteristics can include powerdistributions within specific frequency ranges of the amplified signals.

The leads 106 can record or detect local field potentials (LFPs). LFPscan be low frequency fluctuations of electrical activity below about 500Hz. LFPs can represent the spatial-temporal summation of postsynapticpotentials from local neuronal ensembles in the vicinity of theelectrode. The LFPs can be viewed as a metric of neuronalsynchronization. In Parkinson's subjects, a suppression of beta activityby high-frequency stimulation of the subthalamic nucleus can lead tomotor improvements.

The recording patch 100 can select one or more of the lead's electrodesas stimulating electrodes. The selection of the stimulating electrodescan be based on the signals (or the characteristics thereof) detected orrecorded at the recording patch 100. For example, the recording patch100 can select the electrodes for stimulation that include the mostpower within the beta band.

When the recording patch 100 is not being used to actively recordsignals from the subject 104, the recording patch 100 can be placed intoa stimulation mode (which can also be referred to as a pass-throughmode) and can transmit or forward stimulation signals from theimplantable pulse stimulator 102 to the leads 106. In the pass-throughmode, the recording patch 100 does not substantially affect thestimulation signal generated by the implantable pulse stimulator 102 asthe stimulation signal passes through the recording patch 100. Forexample, the voltage and current of the stimulation signal can besubstantially the same when entering and exiting the recording patch100.

The implantable pulse stimulator 102 can generate therapeutic,electrical stimulations that can be delivered to the subject's brain orother locations by leads 106. The implantable pulse stimulator 102 canbe implanted into the subject 104 at a surgical site remote to therecording patch 100 and the leads 106. For example, the implantablepulse stimulator 102 can be implanted into a surgically created pocketin the subject's chest, between the skin and muscle. The implantablepulse stimulator 102 can generate stimulation signals that pass to thesubject 104 via the cables 108, recording patch 100, and lead 106. Thestimulation signal can include a plurality of wave forms including, butnot limited to, pulses, charged balanced pulses, sinusoidal waves,square waves, triangle waves, and combinations thereof. The electricalstimulation can provide a therapeutic benefit to the subject, such as,suppressing beta activity.

The implantable pulse stimulator 102 can be a stimulating only device.For example, the implantable pulse stimulator 102 does not receivebiological signals from the subject. The implantable pulse stimulator102 can be a stimulating and recording device. For example, theimplantable pulse stimulator 102 can both generate and outputstimulation signals and also receive biological signals that theimplantable pulse stimulator 102 digitizes and stores.

The system 50 can include a plurality of cables 108. One or more cables108 can interconnect the recording patch 100 and the implantable pulsestimulator 102 and the recording patch 100 and the leads 106. Each cable108 can include a plurality of conductors to independently carry aplurality of signals between the components connected with the cable108. For example, the lead 106 can have 12 electrodes and the cable 108can include a dedicated conductor for each of the different electrodes.For each conductor within the cable 108, the cable 108 can include aterminal or connector at each end of the cable 108.

The system 50 can include one or more leads 106. The system 50 caninclude a lead 106 for each recording patch 100. The lead 106 can be amultielectrode lead. The lead 106 can include a distal end and aproximal end. The distal end can include a plurality of electrodes. Theproximal end can include a plurality of terminal contacts. Each of theterminal contacts can be electrically coupled with at least one of theelectrodes. For example, a wire (or other electrical trace) can runthrough the interior of the lead 106 from one of the terminal contactsto a contact disposed toward the distal end that is in electricalcommunication with the electrode. The lead 106 can be a MEMS-based lead106. For example, the lead 106 can include a MEMS film that includes aplurality of electrodes. The MEMS film can be manufactured as a planarfilm. The MEMS film can be heated and molded to form a cylinder. Thecylinder can be backfilled with a polymer to electrically encapsulatethe connections of the lead 106 and fill the cylinder's lumen. The lead106 can be a lead as described in U.S. Pat. No. 9,474,894, which isherein incorporated by reference in its entirety.

FIGS. 4-6 illustrate enlarged views of the recording patch 100. Therecording patch 100 can include a plurality of ports 400. The ports 400can include a plurality of connections 402. The ports 400 can includescrews 412 to secure the cables 108 into the ports 400. The recordingpatch 100 can include an antenna 404 for receiving power from anexternal source and to transmit and receive data with an externalsource. The recording patch 100 can include a controller 406 to controldata exchange and a plurality of switches that interconnect the ports400 with a recording module. The housing 408 of the recording patch 100can include a pass-through port 414 through which the lead 106 passes.The housing 408 can include a screw 410 that can be used to secure therecording patch 100 to the subject's skull.

The recording patch 100 can include a plurality of ports 400. Therecording patch 100 can include a first port 400 and a second port 400.One of the ports 400 can be configured to receive a connection from thepulse stimulator 102. One of the ports 400 can be configured to receivea connection from the lead 106.

The ports 400 can be male connections, female connections, or acombination thereof. For example, one port 400 can be a female connectorand a second port 400 can be a male connector. The ports 400 can eachinclude a plurality of connections 402. For example, for a female port400, the plurality of connections 402 can be distributed along the axiallength of the port's internal lumen. For a male port 400, theconnections 402 can be distributed along the axial length of the port'sbarrel.

Each of the connections 402 can be ring-based electrical contacts. Ateach axial position of the connections 402 along the port 400, theconnections 402 can include a metal layer around the circumference ofthe port's lumen. The connections 402 can be springed or hinged pinsthat can depress onto a contact of the cable 108 when the cable 108 isinserted into the port 400. The cable 108 can include a plurality ofcontacts along its tip. Each of the cable's contacts can align with oneof the connections 402 when the cable 108 is inserted into the port 400.Each port can include between about 2 and about 64, between about 6 andabout 64, between about 12 and about 64, or between about 8 and about 32connections 402. The connections 402 can include Platinum-Iridium,MP35N, or other medical implantable conductive metal.

The port 400 can include a mechanism to secure the cable 108 to therecording patch 100. For example, each port 400 can include a screw 412.The screw 412 can be a blunt tipped screw such that the screw 412 doesnot puncture the cable 108. Once the cable 108 is inserted into the port400, the screw 412 can be tightened onto the cable 108 to secure thecable 108 in place. The mechanism to secure the cable 108 into place caninclude a lure-lock or other type of latching system.

The recording patch 100 can include an antenna 404. The antenna 404 canbe a wire coil that is embedded within the body of the housing 408. Theantenna 404 can be a plurality of electrical traces etched onto acircuit board to which the other components (e.g., the controller 406and power supply) are coupled.

The diameter of the antenna 404 can be selected to enable the antenna404 to efficiently couple with an external source, such as an externalprogrammer, power source, or data storage device (each of thesefunctions can be performed by a single, external device). The antenna404 can enable the recording patch 100 to wirelessly communicate with anexternal programmer over the 27 MHz frequency. Other frequencies whichcould be used are any of those determined by the InternationalTelecommunication Union Radiocommunication Sector (ITU-R) in theirreserved Industrial, Scientific, and Medical (ISM) Bands such as forexample, but not limited to, 6.780 Mhz, 13.560 MHz, 40.680 MHz, 2.450GHz, 5.80 GHz. The antenna diameter can be inversely proportional to thewavelength of the signal the antenna 404 transmits over. For example,with a 27 MHz frequency the loop diameter of the antenna 404 can beabout 25 mm in diameter. In general, the loop diameter of the antenna isabout half the wavelength of the frequency used to communicate with theantenna.

The antenna 404 can be used to inductively receive power from anexternal power source. The recording patch 100 can have no internalpower source. In this case the inductively coupled power from theexternal source can be used to power the recording patch 100. Theexternal power source can provide sufficient power to power therecording patch 100 during recording operations. For example, therecording patch 100 can inductively receive between about 5 mW and about15 mW when in operation. The recording patch 100 can include an internalpower source, such as a battery. The recording patch 100 can rechargethe battery by inductively receiving power via the antenna 404, which isstored in the battery.

The antenna 404 can be used to transmit data between the recording patch100 and an external source. For example, the recording patch 100 canreceive electrical signals from the lead 106. The electrical signals canbe biological signals, such as electrical signals generated by thesubject's brain. The recording patch 100 can amplify the receivedsignals. The recording patch 100 can digitize the signals. The recordingpatch 100 can transmit the digitized signals to the external source viathe antenna 404. The antenna 404 can also receive configurationinformation from the external source. For example, via the antenna 404,the recording patch 100 can receive configuration information that putsthe recording patch 100 into a pass-through mode or a recording mode.The configuration information can include connection information. Theconnection information can include instructions for the interconnectionof the first port's connections 402 with the second port's connections402.

The recording patch 100 can include a controller 406. The controller 406is also described further in relation to FIG. 8, among others. Thecontroller 406 can include one or more amplifies. For example, thecontroller 406 can include an amplifier for each of the channels cominginto the recording patch 100 from the lead 106. The amplifiers can beconfigured to amplify the signals before the signals are transmitted toan external source.

The controller 406 can include different modules. For example, thecontroller 406 can include a recording module that controls therecording and digitization of the signals coming into the recordingpatch 100 from the lead 106. The controller 406 can include a selectormodule. The selector module can determine which of the lead's electrodesshould be used to deliver electrical stimulation to the subject. Forexample, based on a power distribution within the beta band, theselector module can select and configure which of the connections in theport 400 going to the lead 106 should be coupled with connections inport 400 going to the pulse stimulator 102.

The selector module can select the electrodes to use for stimulationbased on the signal characteristics of the signals received from thelead 106. The characteristics can be the amount of power in a beta bandof the received signals. The beta band can be between about 10 Hz andabout 30 Hz, for example. The selector module can select the electrodesthat include the most power in the beta band.

The components of the recording patch 100 can be enclosed within ahousing 408. For example, the controller 406 and the antenna 404 can becontained within an internal space of the housing 408. The housing 408can be manufactured from plastic or be a hermetically sealed titaniumcase. The housing 408 is molded around the components of the recordingpatch 100. The housing 408 can include one or more electrode sites toenable the housing 408 to be used as a ground or reference for therecordings made at the lead 106. The housing 408 can be metal and thehousing 408 itself can be used as a ground or reference electrode. Thehousing 408 can be implemented in Titanium, Titanium Dioxide, Ceramic,Polymer, or any material that conductive or capacitive, biocompatible,and maintains the inner contents sealed.

The housing 408 can include a convex shape that enables the recordingpatch 100 to be secure against the subject's skull. The convex shape ofthe recording patch 100 can substantially match the curvature of thesubject's skull. The housing 408 can be flexible to conform to thecurvature of the subject's skull. The housing 408 can be secured to thesubject's skull with a screw 410.

The housing 408 can include a pass-through port 414. The pass-throughport 414 can be configured to receive and hold the lead 106 or bodythereof. The pass-through port 414 can include a lip 416 that mates withthe burr hole (in the subject's skull) through which the lead 106 isimplanted into the subject's brain. For example, the lip 416 can extendbetween about 1 mm and about 5 mm below the portion of the housing 408including the pass-through port 414. The outer diameter of the lip 416can be substantially the same or slightly less than the inner diameterof the burr hole such that the lip 416 can be press fit into the burhole by the implanting surgeon.

The pass-through port 414 can be used to stabilize and secure the lead106. The pass-through port 414 can be used to seal the burr hole. Forexample, the pass-through port 414 can include a flexible material thatincludes a slit. The lead 106 can pass-through the slit in the flexiblematerial, which can seal around the lead 106. The sealed flexiblematerial can prevent contaminants from entering the burr hole and can beimplemented as an elastomer or polymer, such as a medical gradeSilicone. The housing 408 can also include a burr hole cap that cancover and seal the pass-through port 414.

FIGS. 7A and 7B illustrate an example recording patch 100. FIG. 7Aillustrates a top view of the recording patch 100. FIG. 7B illustrates aperspective view of the recording patch 100. Referring to FIGS. 7A and7B together, the recording patch 100 can include a housing 700 that iscoupled with the subject's skull via an anchor 702. The housing 700 caninclude ports 704(1)-704(3), which can be referred to as ports 704.

The components of the recording patch 100 can be enclosed within thehousing 700. For example, the housing 700 can house a controller 406 andthe antenna 404 as described above in relation to FIG. 6, among others.The housing 700 can be manufactured from plastic or be a hermeticallysealed titanium case. The housing 700 can be molded around thecomponents of the recording patch 100. The housing 700 can include oneor more electrode sites to enable the housing 700 to be used as a groundor reference for the recordings made at the lead 106. The housing 408can be metal and the housing 408 itself can be used as a ground orreference electrode.

The housing 700 can be configured in a “radial” or “spoke and hub”configuration. In these configurations, the housing 700 can include aplurality of spokes 706 that radiate out from a central hub 708. Each ofthe spokes 706 can terminate with or otherwise include at least one port704. The housing 700 can include between about 2 and about 10, betweenabout 2 and about 8, between about 2 and about 6, or between about 2 andabout 4 spokes 706.

The recording patch 100 can include a plurality of spokes 706. Eachspoke 706 can include one or more ports 704. Each spoke 706 may includeonly input ports 704 or only output ports 704, or a combination thereof.Each port can include between about 2 and about 64, between about 2 andabout 32, or between about 2 and about 12 contacts to make an electricalconnection with the contacts of leads 106 or cables 108. The spokes 706or a portion thereof can be flexible to enable the recording patch 100to conform to the shape of the subject's skull. For example, the distalportion of the spokes 706 can include a strain relief that enablesflexing at or near the ports 704. The recording patch 100 can include aflexible or mechanical joint at the connection between the spokes 706and the hub 708 to enable the spokes 706 to deflect and conform to theshape of the subject's skull. The spokes 706 can project from the hub708 at a predetermined angle to conform to the shape of the subject'sskull. The housing 700, from a side profile, can include a convex shapethat enables the recording patch 100 to be secure against the subject'sskull. The convex shape of the recording patch 100 can substantiallymatch the curvature of the subject's skull. The housing 700 can beflexible to conform to the curvature of the subject's skull.

The recording patch 100 can include a plurality of ports 704. Therecording patch 100 can include one or more input ports 704 and one ormore output ports 704. The input ports 704 can electrically couple withthe pulse generator 102 and the output ports 704 can electrically couplewith the leads 106. For example, a port 704 can receive a connectionfrom the cable 108. The ports 704 can be similar to the ports 400described above in relation to FIG. 4. For example, the ports 704 caneach include connections 402 that make electrical contact with thecontacts of the lead 106 or the cable 108. The ports 704 can include oneor more screws 410 to secure a cable 108, cable to a lead 106, or othercable to the ports 704.

The output ports 704 can electrically couple with a lead 106. The ports704 (both the input or output ports 704) can be female or male ports.For example, the input port 704 can be a female port and the outputports 704 can be male ports. The output ports 704 can include a cabletether. The cable tether can include a connector to couple the lead 106with the recording patch 100. The leads 106 can be permanently coupledwith the output ports 704. For example, a cable can extend from theports 704. The distal end of the cable can include the lead 106. Thelead 106 can be permanently coupled with an output port 704 when thecable or port 704 does not include a connector that enables the lead 106to be disconnected form the recording patch 100.

The recording patch 100, as illustrated in FIGS. 7A and 7B can includean anchor 702. The anchor 702 can be a component that separates from thehousing 700. For example, the anchor 702 can be a separate bracket thata medical professional can use to couple the recording patch 100 to thesubject's skull. The anchor 702 can be an integral portion of thehousing 700. For example, the anchor 702 cannot be separated from thehousing 700. The anchor 702 can include a plurality of arms 710. Thearms 710 can extend between each of the spokes 706. The arms 710 canterminate with an anchor point. The anchor point can be an opening orhole to receive a screw 410. A screw 410 can be placed through each ofthe anchor points and screwed into the subject's skull to couple therecording patch 100 to the subject's skull. The anchor 702 can include amedical grade metal, such as stainless steel or titanium

FIG. 8 illustrates a block diagram of an example schematic of the system50. The system 50 can include the recording patch 100 and a programmer800, which can be more generally referred to as an external source or atransmitter and receiver. The recording patch 100 can include thecontroller 406, which can include a recording module 802 and a selectormodule 804. The recording patch 100 can include switches 806 that caninterconnect the controller 406 and ports 400. The recording patch 100can include a power source 808 and the antenna 404. The system 50 caninclude the programmer 800. The programmer 800 can include an instanceof the selector module 804, an antenna 404, and a memory element 810.The recording patch 100 can include the controller 406. The controller406 can include the recording module 802. The recording module 802 caninclude a plurality of amplifiers. For example, the recording module 802can include an amplifier for each of the lead's channels.

The controller 406 can be an application specific integrated circuit(ASIC). Each of the electronic components of the recording patch 100 canbe components of the controller 406. For example, the switches 806, theantenna 404, and the power source 808 can each be components ofcontrollers ASIC. The controller 406 and components of the recordingpatch 100 can be divided among a plurality of ASICs.

The recording module 802 can pass the incoming signals from the lead 106through its amplifiers to generate amplified signals based on theincoming signals. The amplifiers can have a gain between about 50 timesto 5000 times, or between about 60 dB-120 dB. The recording module 802can digitize the amplified signals. The recording module 802 candigitize the signals at a rate of between about 10 Hz and about 2000 Hz,between about 50 Hz and about 1000 Hz, or between about 50 Hz and about20,000 Hz. The recording module 802 can perform pre-processing on theoriginal or amplified signal. The pre-processing can include applyinglow, high, or band pass filters. For example, the recording module 802can band pass the original signal to remove electrical noise. Therecording module 802 can band pass filter the signals to remove all butdesired frequency ranges or bands. For example, the recording module 802can filter the signals to remove frequencies in the signals above about100 Hz, 250 Hz, or about 500 Hz.

The recording module 802 can communicate with the programmer 800 via theantenna 404. The recording module 802 can transmit the amplified signalto the programmer 800 via the antenna 404. The controller 406 caninclude the selector module 804. The recording patch 100 and theprogrammer 800 can each include instances of the selector module 804. Insome examples, only one of the recording patch 100 or the programmer 800include an instance of the selector module 804. For example, only theprogrammer 800 may include an instance of the selector module 804 andthe recording patch 100 can transmit data (e.g., electrical signals) tothe programmer 800 for analysis.

The selector module 804 can select one or more electrodes of the lead106 over which a stimulation signal is delivered to the subject. Theselector module 804 can select the electrodes to use for stimulationbased on the signal characteristics of the signals received from thelead 106. The characteristics can be the amount of power in a beta bandof the received signals. The beta band can be between about 10 Hz andabout 30 Hz, for example. The selector module 804 can select theelectrodes that include the most power in the beta band as theelectrodes to use for stimulation. The selector module 804 can selectthe electrode with the highest amount of power in the beta band as astimulating electrode. The selector module 804 can select the electrodeshaving power in the beta band over a predetermined threshold as thestimulating electrodes. In some implementations, the electrode with themost power in the beta band can be selected. If a plurality ofelectrodes have power in the beta band, each of the plurality ofelectrodes can be selected as a multitude. If a multitude of electrodesis selected they may stimulate at the same signal amplitude, or atdifferent signal amplitudes. If at different signal amplitudes, theindividual single amplitudes applied to each electrode may be chosen tobe proportional to the power of beta band detected. For example, if twoelectrodes display beta band power upon recording, with a firstelectrode demonstrating twice as much power as a second electrode, thesignal amplitude for each electrode would be chosen such that the firstelectrode would have a signal amplitude twice as that of the secondelectrodes. In another use scenario, the signal amplitude could beapplied between two or more electrodes that have each demonstrated betaband power.

The recording patch 100 can include a plurality of switches 806. Theswitches 806 can be components of the controller 406. The switches 806can selectively interconnect the connections in the port 400 leading tothe pulse stimulator 102 to the connections in the port 400 leading tothe lead 106. The switches 806 can selectively interconnect theconnections in the port 400 leading to the lead 106 to the recordingmodule 802. Selectively interconnecting, via the switches 806, caninclude connecting any of a port's connections to any input pins of thecontroller 406 or other connections of another port 400. In someimplementations, the switches can be implemented as mechanical relays,micromechanical MEMS relays, electrical switches such as JFET, MOSFET,or other FET technology, or other microfabrication technology. In someembodiments, no switches are necessary, but a high impedance input tothe recording module would be required. From this input a recordingsignal with high signal to noise can be captured, but stimulation signalfrom the pulse generator 102 would not sink.

The controller 406 can control the switches 806 to put the recordingpatch 100 into a recording mode or a pass-through mode. For example, thecontroller 406 can control the opened or closed state of the switches806. During a pass-through mode, the switches 806 can couple theconnections of a first port 400 with the connections of a second port400. The pass-through mode can enable stimulation signals from the pulsestimulator 102 to pass through the recording patch 100 and to the lead106 without substantial alteration at the recording patch 100.

During a recording mode, the switches 806 can couple the connections ofthe port 400 coupled with the lead 106 with the controller 406. Theswitches 806 can couple each of the lead's electrodes with thecontroller 406 or only a portion thereof.

The recording patch 100 can include a power source 808. The power source808 can be a rechargeable battery. The power source 808 can include asuper capacitor. The power source 808 can be recharged wirelessly viathe programmer 800. For example, the antenna 404 of the programmer 800and the recording patch 100 can inductively couple to provide therecording patch 100 with power. The power can be passed to the powersource 808 to charge the power source 808.

The programmer 800 can be an external data processing system. Theprogrammer 800 can be a stand-alone device. The programmer 800 can be amobile device such as a laptop, tablet, or smart phone. The programmer800 can read and write data to the recording patch 100 through wirelesscommunication with the recording patch 100 using the antennas 404. Forexample, the programmer 800 can receive and store digitized biologicalsignals from the recording patch 100. The programmer 800 can transmitconfiguration information, such as which connections of the ports tointerconnect, to the recording patch 100.

The programmer 800 can include a screen to provide visual information tothe user. The information can include readouts of the electrical signalsreceived at each of the lead's electrodes, power within specified bands(e.g., the beta band) of the signals, or settings (e.g., whichelectrodes are configured as stimulation electrodes). The screen can bea touch screen. The programmer 800 can include an antenna 404 that canbe inductively coupled with the antenna 404 of the recording patch 100to transmit data and power to between the devices. Via the screen theselector module 804 can display one or more characteristics of thereceived signals. Via the screen the selector module 804 can displayplots of power within, for example, the beta band. Via the screen theselector module 804 can display indications or approximations of thesignals' characteristics. For example, the selector module 804 canindicate whether a given channel has a “low,” “medium,” or “high” levelof power in the beta band.

The programmer 800 can include an antenna 404. The antenna 404 of theprogrammer 800 can have a diameter that provides efficient communicationwith the patch 100 via the antenna 404 of the patch 100. For example,the antenna 404 of the programmer 800 can have a diameter between about25 mm and about 85 mm or between about 45 mm and about 55 mm while theantenna 404 of the patch 100 can have a diameter between about 15 mm andabout 35 mm or between about 20 mm and about 30 mm. The programmer 800can communicate with the patch 100 wirelessly after the implantation ofthe patch 100. The programmer 800 can send data to the patch 100 inorder to set the recording parameters that the patch 100 uses to recordelectrical signals via the lead 106. For example, the programmer 800 canset which electrodes are used for the recording and the samplingfrequency that is used to make the recording.

The programmer 800 can download data (e.g., usage data, recordedphysiological data, or device configuration information) from the patch100. The programmer 800 can receive the data from the patch 100 insubstantially real time (e.g., the data can be streamed to theprogrammer 800 from the patch 100). The patch 100 can transmit the datato the programmer 800 in batches. For example, the patch 100 can includean on-board memory to which the recordings from the lead 106 are storedand then downloaded or transmitted to the programmer 800. Once receivedby the programmer 800, the programmer 800 can store the data on thememory 810. A user can later download the recording data from the memory810 to a data processing system for analysis. The programmer 800 canperform all or portions of analysis performed by the data processingsystem.

The programmer 800 can be used to recharge the internal batteries of thepatch 100. For example, the antenna 404 of the programmer 800 can beused to inductively couple power from an external power source to thepatch 100. In some implementations, the patch 100 can have no internalpower source and inductive power from the programmer 800 can be used topower the patch 100.

The programmer 800 can include an instance of the selector module 804.The programmer's selector module 804 can perform any of the functionsperformed by the recording path's selector module 804. For example, theselector module 804 can calculate characteristics of the signalsdetected by the leads 106 and select one or more electrodes of the lead106 over which a stimulation signal is delivered to the subject. Theselector module 804 can select the electrodes to use for stimulationbased on the signal characteristics of the signals received from thelead 106. The characteristics can be the amount of power in a beta bandof the received signals. The beta band can be between about 10 Hz andabout 30 Hz, for example. The selector module 804 can select theelectrodes that include the most power in the beta band as theelectrodes to use for stimulation. The selector module 804 can selectthe electrode with the highest amount of power in the beta band as astimulating electrode. The selector module 704 can select the electrodeshaving power in the beta band over a predetermined threshold as thestimulating electrodes.

FIG. 9A illustrates a block diagram of an example method 900 to recordbiological signals. The method 900 can include implanting a recordingpatch (ACT 902). The method 900 can include coupling a plurality ofconnections with a recording module (ACT 904). The method 900 caninclude receiving biological signals (ACT 906) and generating amplifiedsignals (ACT 908). The method 900 can include determiningcharacteristics of the signals (ACT 910). The method 900 can includeselecting electrodes (ACT 912).

The method 900 can include implanting a recording patch (ACT 902). Therecording patch can be any of the recording patches described herein.The recording patch can be implanted into a subject. The recording patchcan include a first port that is configured to receive a connection froman implantable pulse stimulator. The first port can include a firstplurality of connections. The recording patch can include a second portthat can be configured to receive a connection from an implantable leadthat is implanted into the subject. The lead can include a plurality ofelectrodes. The second port can include a second plurality ofconnections. The recording patch can include a plurality of switchesthat can be in electrical communication with the first plurality ofconnections and the second plurality of connections. The recording patchcan include a recording module that is executed by one or moreprocessors of the recording patch. The recording patch can include aninstance of a selector module.

The recording patch can be implanted beneath the subject's scalpfollowing the implantation of one or more leads into the subject'sbrain. The leads can include a plurality of electrodes. The lead caninclude a plurality of electrodes positioned around the circumference ofthe lead at plurality of different axial locations. For example, at aplurality of different axial locations along the body of the lead'sbody, the lead can include an electrode at 0, 120, and 240 degrees. Thelead can be implanted such that the lead's electrodes are positionedwithin the subject's subthalamic nucleus.

The method 900 can include coupling a plurality of connections with arecording module (ACT 904). The patch 100 can include a first and asecond port. One port can be coupled with an implanted lead and bereferred to as a lead port and one port can be coupled with an implantedstimulator and be referred to as a stimulator port. At a first timepoint after the implantation of the recording patch, the recording patchcan wirelessly receive instructions that place the recording patch in arecording mode. In the recording mode, the recording patch's switchescan couple one or more of the lead port's connections to the recordingmodule. During the recording mode, the recording patch can inductivelycouple with a programmer or other external source to wirelessly receivepower that powers the recording patch.

At a second time point before or after the recording patch collectsrecordings of biological signals from the subject, the recording patchcan receive instructions can cause the recording patch to configure oneor more of the switches in a pass-through configuration such that theswitches couple connections of the lead port with connections of thestimulator port. In a pass-through configuration, the connectionsbetween the first port and the second port can bypass the recordingmodule and stimulation signals can be delivered to the subject prior toor after the recording phase.

The method 900 can include receiving biological signals (ACT 906).During the recording mode, the recording patch can receive biologicalsignals. The recording patch can receive the biological signals via theone or more electrodes that are connected to the lead port's connectionsto pass the biological signals to the recording module. The biologicalsignals can be electrical activity generated by the brain or otherneurological tissue. For example, the biological signals can be LFPs.

The subject can perform physical acts during the receiving and recordingof the biological signals. For example, the subject can perform one ormore of, but not limited to, the following acts on one side or bothsides of the body simultaneously: general movement, rest entire body,moving upper limbs, moving fingers, moving wrists, moving elbows, movinglower limbs, moving toes, moving ankles, moving knees, moving thighs,moving hips, moving extremities, moving head, moving neck, talking,clearing throat, swallowing, coughing, and speaking.

The method can include generating amplified signals (ACT 908). The patchcan include one or more amplifies. The patch can pass the biologicalsignals through the amplifies to generate amplified signals. Theamplifiers can have a gain of between about 50 and about 5000× orbetween about 60 dB and about 120 db. The recording patch can sample thebiological signals at between about 1 kHz and about 32 kHz, betweenabout 8 kHz and about 32 kHz, between about 12 kHz and about 32 kHz, orbetween about 24 kHz and about 32 kHz.

The recording patch can perform pre-processing on the biological signalsor the amplified signals. The pre-processing can include band passfiltering, high or low pass filtering, smoothing, down sampling, upsampling, or a combination thereof. For example, the signals can be bandpass with a filter having a pass band between about 5 Hz and about 5kHz. The pre-processing can include applying a notch filter (at about 50Hz or about 60 Hz) to remove power-line noise. The recording patch canperform the pre-processing digitally once the biological signals aredigitized by the recording module or by one or more analog filters thatcan process the biological signals prior to the digitization of thebiological signals.

The method 900 can include determining characteristics of the signals(ACT 910). The characteristics of the signals can be determined by therecording patch's recording module or selector module. The recordingpatch's controller can determine the characteristics of the biologicalsignals or the amplified signals. The recording patch can alsowirelessly transmit the amplified signal to an external device (e.g., aprogrammer or other device) that can determine the characteristic of thesignals. An instance of the selector module executed by the recordingpatch and an instance of the selector module executed by a programmercan cooperatively work to determine the characteristics of the signals.For example, the recording patch can perform pre-processing andfiltering and then the programmer's instance of the selector module candetermine the power within the beta band of the signals.

The characteristic of the signals can be a power level in a beta band ofeach of the amplified biological signals. The recording patch or theexternal device can divide the amplified biological signals into aplurality of segments. For example, the biological signals can bedivided into 15 second segments. The power in each segment can becalculated using the Welch method using a 1 second Hanning window with afrequency resolution of 1 Hz. The power of different frequency bands canbe calculated as the area under curve of the power spectral densitycurves. For example, the recordings can be divided into a plurality ofbands, such as alpha (7.5-12 Hz), low beta (12.5-16 Hz), medium beta(16.5-20 Hz) and high beta (20.5-30 Hz).

The method 900 can include selecting electrodes (ACT 912). The method900 can include selecting an electrode of the plurality of electrodesbased on the at least one signal characteristic of the biologicalsignal. For example, the controller or the programmer can select each ofthe electrodes that received a biological signal having a power in thebeta band above a predetermined threshold. The controller or theprogrammer can select the electrode that received a biological signalhaving the highest power in the beta band. The one or more selectedelectrodes can be used as stimulating electrodes. The selector modulecan select the electrode at each axial position with the highest powerin the beta band. In some implementations, the selector module canselect a plurality of electrodes. For example, the selector module canselect the plurality of electrodes with the two, three, etc. highestlevel of power in the beta band.

At a time point after the stimulating electrodes are selected, therecording patch can connect the implantable pulse stimulator to theselected electrodes. For example, the connections electrically coupledwith the pulse stimulator can be coupled with the connections at thelead port that are in electrical communication with the selectedelectrodes. The recording patch can place the switches in a pass-throughconfiguration such that the switches couple the connections of the twoports together while bypassing the controller.

When in the pass-through configuration, the pulse stimulator cangenerate a stimulation signal that is transmitted to the selected leadsvia the recording patch. Once the patch is configured into thepass-through configuration, the external power supply from the recordingpatch can be removed. The external power supply can be removed prior totransmitting the stimulation signal to the electrodes selected asstimulation electrodes. The acts of the method 900 can be repeated atpredetermined time points or intervals. For example, during doctorvisits the physician can place the recording patch into a recording modeto retrieve electrical signals from each of the electrodes and theselector modules can re-determine which of the electrodes are receivingelectrical signals with the highest power in the beta band. Duringdifferent iterations of the method 900, different electrodes can beselected as stimulating electrodes. For example, during a firstiteration of the method 900 a first plurality of the electrodes can beselected as stimulation electrodes. At another time point during asecond iteration of the method 900 a second plurality of electrodes(which can be a subset of the first plurality of electrodes or adifferent plurality of electrodes) can be selected and coupled with therecording module.

FIG. 9B illustrates a block diagram of an example method 920 to receivebiological signals. The method 920 can be used in conjunction with theACTs of the method 900. For example, the method 920 can be used at ACT908 of the method 900. The method 920 can include collecting restingsignals (ACT 922). The method 920 can include asking a subject toperform an action (ACT 924). The method 920 can include collectingsignals during the action (ACT 926). The method 920 can includedetermining whether the subject should perform another activity (ACT928). The method can include stimulating the subject (ACT 930). Themethod 920 can include receiving biological signals (ACT 932).

As set forth above, the method 920 can include collecting restingsignals (ACT 922). The signals can be biological signals. For example,the biological signals can be electrical activity generate by brain orother neurological tissue. For example, the biological signals can beLFPs. The subject can be asked to relax or otherwise not move as theresting signals are collected. For example, the subject can be asked torecline, sit, or lie down as the recording patch collects the signals.To record the signals, the programmer can set the recording patch to therecording mode. The recording patch can receive the biological signalsvia the one or more electrodes of the lead. The recording patch cancollect or otherwise record the resting signals as the subject rests(e.g., does not substantially move). The recording patch can collect theresting signals at a predetermined time interval after the subjectbegins to rest. For example, the subject can be asked to recline and therecording patch can begin to collect the resting signals about 1 minute,5 minute, 10 minutes, or 15 minutes after the subject begins to recline.

The method 920 can include asking the subject to perform an activity(ACT 924). A medical professional can request that the subject performan activity or action when prompted by the programmer. The activity caninclude moving certain parts of the body, walking, turning, standing,coughing, speaking, throat clearing, swallowing, blinking, winking,squinting, performing hand gestures, performing finger gestures,performing elbow movements, performing shoulder movements, breathing, orhalting the breath, among others. The medical professional can ask thesubject to physically perform the activity or the medical professionalcan ask the subject to visualize or imagine performing the activity.

The method 920 can include collecting signals during the activity (ACT926). The signals can be biological signal as described above inrelation to ACT 922. The biological signal can be collected as thesubject performs (physically or mentally) the activity of ACT 924. Thesignals can be recorded immediately following the completion ofactivity. For example, the recording patch can record the signals 1 min,5 min, 10 min, 15 min, or 30 min after the completion of the activity.The biological signals recorded at ACT 922 and ACT 926 can becontinuously recorded during a testing session. For example, therecording patch can be placed into a recording mode prior to the medicalprofessional asking the subject to rest and then continue recordingthrough the ACTS of the method 920. The medical professional or theprogrammer can annotate the recorded signal to indicate the transitionsbetween different phases of the testing session. For example, via theprogrammer, the medical professional can indicate when the subjectbegins to rest and when the subject begins or ends the activity. Theprogrammer can record the time of the indication or can set a flag inthe recorded signal to indicate each of the transitions.

The method 920 can include determining whether to test another activity(ACT 928). The programmer can be loaded with testing policy that canindicate the one or more activities that the subject should performduring the method 920. A medical professional can select or configurethe activities stored in the testing policy. The programmer candetermine whether there are additional activities to ask the subject toperform. If there are additional activities to perform, the method 920can return to the ACT 922. For example, determining there are additionalactivities to perform, the programmer can display a message to themedical professional to request that the medical professional ask thesubject to rest. After the recording patch records additional restingsignals (e.g., repeats ACT 922), the programmer can request that themedical professional instruct the subject to perform the next activitylisted in the testing policy (e.g., repeats ACT 924). The recordingpatch can collect the signal during or after the subject completes thenext activity listed in the testing policy (e.g., repeats ACT 926). Themethod 920 can include repeating the ACTs 922-926 until the programmerdetermines there are no more additional activities in the testing policyfor the subject to perform.

The method 920 can include stimulating the subject via the lead (ACT930). Also referring to FIG. 1, among others, the programmer can send aninstruction to the recording patch to place the recording patch in apass-through mode, such that electrical stimulations from the pulsestimulator 102 can pass from the pulse stimulator 102 to the lead 106.As described above, the lead 106 can include a plurality of electrodes.The pulse stimulator 102 can individually address each of the pluralityof electrodes. The programmer can select one or more of the plurality ofelectrodes to which the stimulation should be delivered from the pulsestimulator 102. For example, the pulse stimulator 102 can include aplurality of internal switches that can be opened or closed toelectrically disconnect or connect, respectively, an electrode from astimulation source of the pulse stimulator 102. The pulse stimulator 102can deliver the stimulation single to one electrode, a plurality ofelectrodes, or all of the electrodes of the lead 106.

The method 920 can include receiving biological signals (ACT 932). Toreceive biological signals, the programmer can place the recording patchback into the recoding mode. The recording patch can receive thebiological signals via the one or more electrodes that are connected tothe lead port's connections to pass the biological signals to therecording module. The biological signals can be electrical activitygenerate by brain or other neurological tissue. For example, thebiological signals can be LFPs. The recording patch can receive orotherwise record the biological signal starting at the completion of thestimulation signal delivered at ACT 930. The recording patch cancontinue to record the biological signals for between about 1 min andabout 30 min, between about 1 min and about 20 min, or between about 1min and about 15 minutes following the completion of the stimulationsignal. The ACT 930 and the ACT 932 can be repeated a plurality oftimes. For example, the ACT 930 and ACT 932 can be repeated for eachelectrode of the leads 106.

The method 920 can include determining characteristics of the recordedsignal at different time points. For example, the characteristics of thebiological signal post-stimulation or post-activity can be compared tothe characteristics of the biological signal recording during ACT 922when the subject was at rest. The characteristics of the signals can bedetermined by the recording patch's recording module or selector module.The recording patch's controller can determine the characteristics ofthe biological signals. Determining the characteristics is furtherdescribed in relation to FIGS. 10-14, among others. The recording patchcan also wirelessly transmit the amplified signal to an external device(e.g., a programmer or other device) that can determine thecharacteristic of the signals. An instance of the selector moduleexecuted by the recording patch and an instance of the selector moduleexecuted by a programmer can cooperatively work to determine thecharacteristics of the signals. For example, the recording patch canperform pre-processing and filtering and then the programmer's instanceof the selector module can determine the power within the beta band ofthe signals. The characteristic of the recorded signal can be the amountof power in a beta-band of the recorded signal. For example, therecording patch's controller can determine the change in the amount ofpower in the beta-band between the resting phase (e.g., during ACT 922)and the amount of power in the beta-band after the stimulation signal isprovided to the subject (e.g., during ACT 932).

FIGS. 10-13 illustrate the results of recordings made with a systemsimilar to that described herein. FIG. 10 illustrates a plot 1000 of aplurality of power spectral densities 1002. Each of the power spectraldensities 1002 was generated from 30-second recordings for both movingconditions (top row) and resting conditions (bottom row). Each recordingwas split into fifteen two-second epochs to examine changes in powerspectral densities over time. Across the conditions and subjects, nomarked change was observed over time. Differences were primarilyobserved between subjects in terms of peak frequency (e.g., thefrequency component with most signal energy) and in terms of directions.For example, for subject 1 during moving, peak power was concentratedbetween about 25 and about 30 Hz. Subject 2 showed peak power duringmoving and resting between frequencies about 17 and about 27 Hz. Forsubject 3, peak power was concentrated in a narrow band around 8 Hz.Subject 4 had peak spectral densities between about 8 and about 15 Hz.

FIG. 11 illustrates a plot 1100 of power spectral densities for each offour subjects. The plot 1100 includes separate power spectral densitiesform the different lead electrodes pointed in the antero-lateral,medial, and postero-lateral directions. The plot 1100 illustrates thatthe four subjects experienced directional difference. For example,during moving, subject 1 had peak power in the antero-lateral and medialdirections with slightly less power in the postero-lateral direction.Subject 2 showed peak power in the antero-lateral direction with visiblymore power than in the medial or postero-lateral direction. Duringmoving, subject 3 had most power in the medial direction. Subject 4 hadincreased power below 10 Hz in all three directions during moving, butconcentrated spectral power in the medial direction during resting.

During resting, the power spectral densities showed more directionaldifferences than during moving. For example, subjects 1, 2, and 3 hadheightened activity in the antero-lateral direction with peak power at27 Hz, 22 Hz and 9 Hz, respectively. Subject 4 showed increased activityat 10 Hz in the medial direction.

The power spectral densities were stored as ranked stimulationdirections (e.g., 1st, 2nd, and 3rd best direction) and split the powerspectral densities into four frequency bands (e.g., alpha, low beta,medium beta, and high beta). The directions were ranked from the highestbeta activity to the lowest beta activity.

FIG. 12 illustrates a plot 1200 comparing different frequency bands todifferent stimulation directions. In each of the six plotted examples,the 1st best direction had more power than the 2nd and 3rd bestdirections. However, in half of the cases these directional differencesbetween directions were not significant. For instance, no significantdifference was observed in the alpha frequency band or in the low betafrequency band during moving and resting. Significant differences weredetected in the medium and high beta frequency bands and were morepronounced in the high beta frequency band and was particularly markedduring resting.

FIG. 13 illustrates a comparison 1300 of the spectral power for the twoconditions in the different frequency bands. The first condition ismoving and the second condition is resting. The comparison 1300illustrates that subjects 1 and 2 had most power during resting acrossthe four frequency bands, while subjects 3 and 4 had no preferablecondition. For the medium beta frequency band, moving and resting hadsimilar power in these two subjects.

The above plots in FIGS. 10-13 illustrate that the power spectraldensities showed relevant activity between about 8 Hz and about 30 Hz.The beta band can be linked with motor functions and Parkinson's diseasecan be linked with an increase in beta oscillations in the subthalamicnucleus. On average the highest spectral power for medium and high betabands was observed in the direction matching the 1st best stimulationdirection, e.g., the direction with the largest therapeutic window.

FIG. 14 illustrates an example heat map 1400 to illustrate the amount ofbeta activity recorded at each of the electrodes of the lead during aplurality of activities. The heat map 1400 can indicate the relativeamount of beta activity recorded at each of the plurality of electrodes1406. The amount of beta activity can be calculated or otherwisedetermined as described above in relation to FIGS. 9A-13, among others.For example, the recording patch can record neurological activity as thesubject performs a plurality of activities as described in relation toFIG. 9B. As illustrated in FIG. 14, a test was performed where theamount of beta activity was identified at 6 different electrodes 1406.The electrodes 1406 can correspond to 6 electrodes of the lead 106. Thecontroller can determine the beta activity as (or immediately after) thesubject performs one of a plurality of activities 1402. The heat map1400 can group the activities 1402 into groups 1404. The activities 1402can be grouped based on the region of the body that is activated whenperforming the respective activity. For example, the movement of thearm, bending of the wrist, and movement of the fingers can be groupedinto a group called “upper limbs.” As illustrated in FIG. 14, the heatmap 1400 illustrates the amount of beta activity as the subject: is atrest; talking, clearing the throat; and swallowing (the “mouth” group);moving the arm, bending the wrist, and moving the fingers (the “upperlimb” group); and walking, bending the leg, and rolling the ankle (the“lower limb” group).

The heat map 1400 can be a matrix that visually illustrates, for eachelectrode 1406—activity 1402 combination, a value 1408 of beta activitydetected by the recording patch. The value 1408 can be a color-codedindicator or a value-coded indicator. For example, as illustrated inFIG. 14, relatively low beta activity can be indicated by a lightlycolored box and a relatively high beta activity can be indicated by adarkly colored box. The heat map 1400 can use any color mapping or othervisual representation of values. For example, for a value-codedindicator, the value 1408 can be a scored value between 1 and 10 or arelative term such as “high,” “medium,” or “low.” For each value 1408,the controller can normalize the value 1408 between 0 and 1 (or othervalue). For example, the controller can set the highest beta activityvalue 1408 of the electrode-activity combinations to 1 and the lowestbeta activity value 1408 of the electrode-activity combinations to 0.The values between the highest and lowest electrode-activitycombinations can be scaled between 0 and 1. The scaling can be linear,logarithmic, binary, normalized, or non-linear.

As illustrated in FIG. 14, directional electrodes 2 and 3 demonstrated arelatively high beta activity within the mouth and upper limb groups,respectively. Electrodes 1, 5, and 6 also demonstrated beta activity toa lesser extent. Electrode 4 did not demonstrate any beta activity.Based on the heat map 1400, the programmer could therefore conclude thatdirectional electrode 2 may cause side effects linked to the mouth andthroat region. However, the programmer could conclude that electrode 4would be a good candidate for use in stimulation because of the low betaactivity detected for each of electrode 4's electrode-activitycombinations.

While operations are depicted in the drawings in a particular order,such operations are not required to be performed in the particular ordershown or in sequential order, and all illustrated operations are notrequired to be performed. Actions described herein can be performed in adifferent order.

The separation of various system components does not require separationin all implementations, and the described program components can beincluded in a single hardware or software product.

Having now described some illustrative implementations, it is apparentthat the foregoing is illustrative and not limiting, having beenpresented by way of example. In particular, although many of theexamples presented herein involve specific combinations of method actsor system elements, those acts and those elements may be combined inother ways to accomplish the same objectives. Acts, elements andfeatures discussed in connection with one implementation are notintended to be excluded from a similar role in other implementations orimplementations.

The phraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including” “comprising” “having” “containing” “involving”“characterized by” “characterized in that” and variations thereofherein, is meant to encompass the items listed thereafter, equivalentsthereof, and additional items, as well as alternate implementationsconsisting of the items listed thereafter exclusively. In oneimplementation, the systems and methods described herein consist of one,each combination of more than one, or all of the described elements,acts, or components.

As used herein, the term “about” and “substantially” will be understoodby persons of ordinary skill in the art and will vary to some extentdepending upon the context in which it is used. If there are uses of theterm which are not clear to persons of ordinary skill in the art giventhe context in which it is used, “about” will mean up to plus or minus10% of the particular term.

Any references to implementations or elements or acts of the systems andmethods herein referred to in the singular may also embraceimplementations including a plurality of these elements, and anyreferences in plural to any implementation or element or act herein mayalso embrace implementations including only a single element. Referencesin the singular or plural form are not intended to limit the presentlydisclosed systems or methods, their components, acts, or elements tosingle or plural configurations. References to any act or element beingbased on any information, act or element may include implementationswhere the act or element is based at least in part on any information,act, or element.

Any implementation disclosed herein may be combined with any otherimplementation or embodiment, and references to “an implementation,”“some implementations,” “one implementation” or the like are notnecessarily mutually exclusive and are intended to indicate that aparticular feature, structure, or characteristic described in connectionwith the implementation may be included in at least one implementationor embodiment. Such terms as used herein are not necessarily allreferring to the same implementation. Any implementation may be combinedwith any other implementation, inclusively or exclusively, in any mannerconsistent with the aspects and implementations disclosed herein.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

References to “or” may be construed as inclusive so that any termsdescribed using “or” may indicate any of a single, more than one, andall of the described terms. For example, a reference to “at least one of‘A’ and ‘B’” can include only ‘A’, only ‘B’, as well as both ‘A’ and‘B’. Such references used in conjunction with “comprising” or other openterminology can include additional items.

Where technical features in the drawings, detailed description or anyclaim are followed by reference signs, the reference signs have beenincluded to increase the intelligibility of the drawings, detaileddescription, and claims. Accordingly, neither the reference signs northeir absence have any limiting effect on the scope of any claimelements.

The systems and methods described herein may be embodied in otherspecific forms without departing from the characteristics thereof. Theforegoing implementations are illustrative rather than limiting of thedescribed systems and methods. Scope of the systems and methodsdescribed herein is thus indicated by the appended claims, rather thanthe foregoing description, and changes that come within the meaning andrange of equivalency of the claims are embraced therein.

1-20. (canceled)
 21. An implantable device, comprising: a housing tosecure against a subject; a circuit disposed in the housing, the circuitto: receive, at least partially concurrent with presentation of a promptto the subject to perform an activity, a first biological signal fromthe subject passed via a switch connected with a lead; set, responsiveto completion of the prompt, the switch to connect with a stimulator topass a stimulation signal from the stimulator to the lead; receive,subsequent to passing of the stimulation signal from the simulator, asecond biological signal from the subject passed via the switch with thelead; and determine a characteristic based on the first biologicalsignal and the second biological signal.
 22. The device of claim 21,comprising the circuit to: receive, prior to the presentation of theprompt for the subject to perform the activity, a third biologicalsignal; and determine the characteristic corresponding to a differencebetween the second biological signal and the third biological signal.23. The device of claim 21, comprising the circuit to: receive, at leastpartially concurrent with presentation of a second prompt to the subjectto perform a second activity in accordance with a policy, a thirdbiological signal; and determine a characteristic based on the firstbiological signal for the activity and the third biological signal forthe second activity.
 24. The device of claim 21, comprising the circuitto: select, from a plurality of electrodes of the lead, an electrode todeliver the stimulation signal from the stimulator to the lead based onthe characteristic of the first biological signal; and receive thesecond biological signal from the subject via the electrode of theplurality of electrodes of the lead.
 25. The device of claim 21,comprising the circuit to: record the first biological signal over afirst time window relative to the presentation of the prompt to performthe activity; and record the second biological signal over a second timewindow relative to the passage of the stimulation signal.
 26. The deviceof claim 21, comprising the circuit to determine the characteristicincluding a first power level in a beta-band of the first biologicalsignal and a second power level in a beta-band of the second biologicalsignal.
 27. The device of claim 21, comprising the circuit tocommunicate with a programmer via an antenna to transmit at least one ofthe first biological signal or the second biological signal.
 28. Aprogrammer device, comprising: one or more processors coupled withmemory in communication with a recording patch, configured to: transmita first instruction to set the recording patch to receive, at leastpartially concurrent with presentation of a prompt to the subject toperform an activity, a first biological signal from the subject passedvia a switch connected a lead; transmit a second instruction to set therecording patch to set, responsive to completion of the prompt, theswitch to connect with a stimulator to pass a stimulation signal fromthe stimulator to the lead; transmit a third instruction to set therecording patch to receive a second biological signal from the subjectpassed via the switch connected with the lead; and determine acharacteristic based on the first biological signal and the secondbiological signal from the recording patch.
 29. The device of claim 28,comprising the one or more processors to: select, responsive to adetermination to test the subject to perform another activity, a secondactivity from a plurality of activities in accordance with a policy; andtransmit a fourth instruction to set the recording patch to receive, atleast partially concurrent with presentation of a second prompt toperform the second activity, a third biological signal from the subjectpassed via the switch.
 30. The device of claim 28, comprising the one ormore processors to: determine, subsequent to the completion of theprompt, to not test the subject to perform another activity inaccordance with a policy; and transmit, responsive to the determinationto not test the subject to perform another activity, the secondinstruction to set the switch to connect with the stimulator.
 31. Thedevice of claim 28, comprising the one or more processors to: select,from a plurality of electrodes of the lead, an electrode to deliver thestimulation signal from the stimulator to the lead based on thecharacteristic of the first biological signal; and transmit the thirdinstruction to the recording patch to receive the second biologicalsignal from the subject via the electrode of the plurality of electrodesof the lead.
 32. The device of claim 28, comprising the one or moreprocessors to: record the first biological signal over a first timewindow relative to the presentation of the prompt to perform theactivity; and record the second biological signal over a second timewindow relative to the passage of the stimulation signal.
 33. The deviceof claim 28, comprising the one or more processors to determine thecharacteristic including a first power level in a beta-band of the firstbiological signal and a second power level in a beta-band of the secondbiological signal.
 34. A method, comprising: receiving, by a recordingpatch secured against a skull of a subject, a first biological signalfrom the subject passed via a switch connected with a lead, concurrentwith presentation of a prompt to the subject; setting, by the recordingpatch, responsive to completion of the prompt, the switch to connectwith a stimulator to pass a stimulation signal from the stimulator tothe lead; receiving, by the recording patch, subsequent to passing ofthe stimulation signal from the simulator, a second biological signalfrom the subject passed via the switch connected with the lead; anddetermining, by the recording patch, a characteristic of the firstbiological signal and the second biological signal.
 35. The method ofclaim 34, comprising: receiving, by the recording patch, prior to thepresentation of the prompt for the subject to perform the activity, athird biological signal; and determining, by the recording patch, thecharacteristic corresponding to a difference between the secondbiological signal and the third biological signal.
 36. The method ofclaim 34, comprising: receiving, by the recording patch, at leastpartially concurrent with presentation of a second prompt to the subjectto perform a second activity in accordance with a policy, a thirdbiological signal; and determining, by the recording patch, acharacteristic based on the first biological signal for the activity andthe third biological signal for the second activity.
 37. The method ofclaim 34, comprising: selecting, by the recording patch, from aplurality of electrodes of the lead, an electrode to deliver thestimulation signal from the stimulator to the lead based on thecharacteristic of the first biological signal; and receiving, by therecording patch, the second biological signal from the subject via theelectrode of the plurality of electrodes of the lead.
 38. The method ofclaim 34, comprising: recording, by the recording patch, the firstbiological signal over a first time window relative to the presentationof the prompt to perform the activity; and recording, by the recordingpatch, the second biological signal over a second time window relativeto the passage of the stimulation signal.
 39. The method of claim 34,comprising: determining, by the recording patch, the characteristicincluding a first power level in a beta-band of the first biologicalsignal and a second power level in a beta-band of the second biologicalsignal.
 40. The method of claim 34, comprising: communicating, by therecording patch, with a programmer via an antenna to transmit at leastone of the first biological signal or the second biological signal.